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For Immediate Release
OXYTROL® RECEIVES POSITIVE PBAC RECOMMENDATION
FOR PBS LISTING
—
OXYTROL
®
has been recommended for listing on the PBS —
MELBOURNE, VIC, 24 April 2009 – Hospira, a leading specialty
pharmaceutical and medication delivery company, announced today that
OXYTROL
®
(oxybutynin transdermal drug delivery system), a transdermal patch
for the treatment of overactive bladder (OAB) or urge urinary incontinence
(UUI), has received a positive recommendation from the PBAC (Pharmaceutical
Benefits Advisory Committee) for listing on the PBS (Pharmaceutical Benefits
Scheme) in Australia.
Tim Oldham, Asia Pacific President for Hospira, said "This is a very
positive outcome for many Australians continuing to suffer from certain bladder
conditions, who have failed on existing therapy and cannot afford the higher
cost of private prescriptions. The addition of OXYTROL
®
to the PBS will now
enable affordable access for these patients to the product. More treatment
options for the management of incontinence can provide sufferers with
significant improvement to their quality of life."
There are a number of steps that have to be negotiated before Hospira
can realise a listing date for OXYTROL
®
. Hospira will continue to work with the
PBAC on the listing requirements, and Hospira is optimistic that an agreement
that is satisfactory to both parties can be reached.
OXYTROL® RECEIVES POSITIVE PBAC RECOMMENDATION
FOR PBS LISTING
PAGE 2
About OAB
OAB is characterised by a sudden, uncomfortable need to urinate with or
without urge incontinence (urine leakage), and usually includes more frequent
urination and nocturia (waking up at least once during the night to urinate). The
incidence of urinary incontinence continues to be a growing problem within the
Australian community. Urinary incontinence affects up to 13 percent of
Australian men and up to 37 percent of Australian women
(1)
.
OAB is a complex and widespread health issue affecting people of all
ages and backgrounds. Its effects are distressing and wide-reaching. Its
physical, social and personal consequences can influence and erode a person's
lifestyle and participation in society. Carers also often deal with an increasing
burden in trying to manage incontinence. At-risk groups include people with
disabilities, chronic illness, post-operative complications, women pre- and post-
delivery and the elderly.
About Hospira
Hospira is a global specialty pharmaceutical and medication delivery
company dedicated to Advancing Wellness
™
. As the world leader in specialty
generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios
of generic acute-care and oncology injectables, as well as integrated infusion
therapy and medication management solutions. Through its products, Hospira
helps improve the safety, cost and productivity of patient care. The company is
headquartered in Lake Forest, Illinois, United States and has more than 14,000
employees. The head office for Hospira in Asia-Pacific is located in Melbourne,
OXYTROL® RECEIVES POSITIVE PBAC RECOMMENDATION
FOR PBS LISTING
PAGE 3
For further information, please contact Charlie O'Sullivan on 03 9868
0137.
References:
1.
Continence Foundation of Australia Web site – Facts and Figures.
Review Full Product Information before prescribing. INDICATIONS:
Overactive bladder with symptoms of urinary frequency, urgency and/or
incontinence. DOSAGE: Apply one patch twice weekly to dry, intact skin on the
abdomen, hip, or buttock. Avoid application to the same site within 7 days.
CONTRAINDICATIONS: Urinary or gastric retention, uncontrolled narrow-angle
glaucoma, severe ulcerative colitis, toxic megacolon, myasthenia gravis.
Hypersensitivity to oxybutynin or any components. PRECAUTIONS: Hepatic or
renal impairment, autonomic neuropathy, cognitive impairment, Parkinson's
disease, hyperthyroidism, coronary heart disease, congestive heart failure,
cardiac arrhythmias, tachycardia, hypertension, prostatic hypertrophy, clinically
significant bladder outflow obstruction, gastrointestinal obstructive disorders,
non-severe ulcerative colitis, intestinal atony, gastro-oesophageal reflux,
combined use with medicines that can cause or exacerbate oesophagitis.
Assess for other causes of frequent urination before treatment. Heat prostration,
drowsiness or blurred vision. Caution when driving or operating machinery and
with alcohol. Pregnancy – Category B1. Lactation – excretion unknown.
Interactions: Other anticholinergic agents. ADVERSE EFFECTS: Application
site reactions, dry mouth, dysuria, constipation, diarrhoea, abdominal pain,
nausea, flatulence, abnormal vision, fatigue, somnolence, headache, flushing,
rash, back pain.
Full Product Information is available on request from Hospira Pty Ltd.
OXY V 2.0 05/08. OXYTROL
is a registered trade mark of Watson
Pharmaceuticals, Inc. used under license.
###
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